Mabion

Analytical method development, optimization and validation in Mabion is the foundation of a successful biologics program.

Mabion offers biologics analytical methods, GMP, and release testing services to ensure product regulatory compliance.

Mabion provides solutions for biosimilar characterization and manufacture, leveraging its extensive experience.

Clinical & Commercial cGMP Drug Substance manufacturing. High quality and compliance from cell line development to market for every biologics.

Mabion offers career opportunities in biotechnology and drug development projects.

Mabion provides job offers in biotechnology, professional development, and involvement in biological drug projects.

Mabion's Management Board, Supervisory Board and Committees is founded on the broad and deep experience of the international team members.

Mabion provides access to corporate documents, including its Articles of Association, governance rules, and remuneration policies.

Mabion follows the Good Practices of Listed Companies as the foundation of its corporate governance.

Environmental protection provides a framework for actions aimed at reducing the negative impact of Mabion’s activities on the environment.

Mabion Biologics began as a contract development and manufacturing organization (CDMO) in 2007 in Poland.

Mabion supports pharma and biotech companies with biologic drug development and manufacturing services.

Mabion is a European CDMO partner offering development and production of biological drugs from project to finished product.

Oddifact and Mabion secure an FDA Type B pre-IND meeting for **RTX-NP (MabionCD20)**, a treatment candidate for immune thrombocytopenia (ITP). The meeting aims to align on the development strategy and potential Biologics License Application (BLA) submission. Both companies are progressing their investigational therapeutic program under the FDA’s guidance.

Aug 2026RTTNewsNews article

Oddifact and Mabion secure an FDA **Type B pre-IND meeting grant** to align their development strategy for **RTX-NP (MabionCD20)**, a nanoparticle formulation of rituximab. The companies seek to translate rituximab’s proven efficacy in **immune thrombocytopenia (ITP)** into a formal FDA-approved therapy. The grant facilitates early regulatory dialogue to optimize the path toward clinical approval.

Aug 2026BioSpaceNews article

Mabion S.A. partners with KriSan Biotech to develop and manufacture next-generation antibody-drug conjugates (ADCs). The agreement formalizes their collaboration under a Master Service Agreement (MSA). Both companies focus on advancing ADC therapies, combining Mabion’s expertise with KriSan Biotech’s capabilities in Taiwan.

Jul 2026PharmaSourceNews article

Mabion S.A. extends its contract manufacturing partnership with Novavax, securing the agreement through 2029. The collaboration supports Novavax’s production needs under the expanded terms. The deal follows their existing multi-year relationship in biologics manufacturing.

Jun 2026PharmaSourceNews article